Sobrevida e fatores de risco à falhas de restaurações de resina composta em crianças com cárie de acometimento precoce

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(1)UNIVERSIDADE FEDERAL DE SANTA MARIA CENTRO DE CIÊNCIAS DA SAÚDE PROGRAMA DE PÓS-GRADUAÇÃO EM CIÊNCIAS ODONTOLÓGICAS. Pâmela Campagna. SOBREVIDA E FATORES DE RISCO ASSOCIADOS À FALHAS DE RESTAURAÇÕES DE RESINA COMPOSTA EM CRIANÇAS COM CÁRIE DE ACOMETIMENTO PRECOCE: ESTUDO CLÍNICO RETROSPECTIVO. DISSERTAÇÃO DE MESTRADO. Santa Maria, RS 2017.

(2) Pâmela Campagna. SOBREVIDA E FATORES DE RISCO ASSOCIADOS À FALHAS DE RESTAURAÇÕES DE RESINA COMPOSTA EM CRIANÇAS COM CÁRIE DE ACOMETIMENTO PRECOCE. Dissertação apresentada ao Curso de Mestrado do Programa de Pós-Graduação em Ciências Odontológicas, Área de Concentração em Odontologia, ênfase em Odontopediatria, da Universidade Federal de Santa Maria (UFSM, RS), como requisito parcial para obtenção do grau de Mestre em Ciências Odontológicas. Orientadora: Profa. Dra. Marta Dutra Machado Oliveira. Santa Maria, RS 2017.

(3) Pâmela Campagna. SOBREVIDA E FATORES DE RISCO ASSOCIADOS À FALHAS DE RESTAURAÇÕES DE RESINA COMPOSTA EM CRIANÇAS COM CÁRIE DE ACOMETIMENTO PRECOCE. Dissertação apresentada ao Cursode Mestrado do Programa de Pós-Graduação em Ciências Odontológicas, Área de Concentração em Odontologia, ênfase em Odontopediatria, da Universidade Federal de Santa Maria (UFSM, RS), como requisito parcial para obtenção do grau de Mestre em Ciências Odontológicas. Aprovada em 17 de Julho de 2017. _____________________________________________ Marta Dutra Machado Oliveira, Profa. Dra. (UFSM) (Presidente/Orientador) ______________________________________________ Tathiane Larissa Lenzi (UFSM) ______________________________________________ Bianca Zimmermann dos Santos (UNIFRA). Santa Maria, RS 2017.

(4) DEDICATÓRIA. À meus pais pelo amor, incentivo е apoio incondicional.. Pai e mãe, somente vocês, nesta caminhada silenciosa, para saber quanto sacrifício fizemos para chegar até aqui. Vocês se sacrificaram, se dedicaram, abdicaram de tempo e de muitos projetos pessoais para que eu tivesse a oportunidade de estudar e de ter uma boa formação profissional e também pessoal. Eu devo tudo que sou a vocês, e se sinto orgulho de mim e do lugar onde cheguei, é porque sei que vocês vieram segurando a minha mão. Obrigada por tudo, amo muito vocês! Espero poder retribuir em dobro tudo que fizeram por mim..

(5) AGRADECIMENTOS. “Agradecer é admitir que houve um momento em que se precisou de alguém; é reconhecer que o homem jamais poderá lograr para si o dom de ser auto-suficiente. Ninguém se faz sozinho: sempre é preciso um olhar de apoio, uma palavra de incentivo, um gesto de compreensão, uma atitude de amor. A todos vocês, que compartilharam dos meus ideais, dedico esta vitória com a mais profunda gratidão e respeito.” (Autor desconhecido). À minha orientadora, Professora Marta Dutra Machado Oliveira, que com. dedicação. e. competência,. despertou. meu. amor. pela. Odontopediatria. Sinto muito orgulho de ser orientada por uma profissional que sempre foi muito além do básico, sempre acolheu e tratou a todos, pacientes e alunos, como filhos. Obrigada de coração pela oportunidade, pela paciência, pelo aprendizado, pelo carinho, e acima de tudo, pelo exemplo de pessoa e profissional. À querida e talentosa Professora Tathiane Larissa Lenzi, que contribuiu em todo o trabalho, demonstrando generosidade e competência em tudo. Obrigada pelo apoio e disponibilidade, tua ajuda foi indispensável para este momento. Obrigada também por se dedicar ao seu trabalho com tanto entusiasmo e verdade, te admiro muito. “Há pessoas que marcam a nossa vida, que despertam algo especial em nós, que abrem nossos olhos de modo irreversível e transformam a nossa maneira de ver o mundo.” (Autor desconhecido) À Universidade Federal de Santa Maria, por todo aprendizado e por ser minha casa ao longo destes sete anos. Tenho muito orgulho de ter estudado na UFSM..

(6) À todos professores que contribuíram para minha formação, em especial aos professores de Odontopediatria da UFSM. Professora Rachel Rocha, que também contribuiu para o desenvolvimento deste trabalho, e além disto, sempre esteve disposta a ensinar e ajudar, obrigada querida pela generosidade, carinho e motivação, você é um exemplo para mim. ProfessorThiago Machado Ardenghi, que além de ter contribuído neste trabalho, foi uma das pessoas mais inteligentes e humildes que já conheci, grande exemplo de professor e pessoa. Professor Leandro Osório, exemplo de dedicação e amor pela profissão, obrigada por todo aprendizado e pela alegria diária, sinto muito orgulho de ter sido tua aluna. Aos queridos funcionários da Clínica de Odontopediatria, Dalvinha, Denise, Silvandro, Dona Vera, Soninha, obrigada pela dedicação e auxílio, pelas conversas e conselhos, vou sentir muitas saudades... Ao Programa de Pós-Graduação em Ciências Odontológicas (PPGCO) e aos seus professores pelo aprendizado, dedicação, e disposição em ajudar sempre. Às minhas queridas colegas de mestrado, pelo companheirismo e ajuda, sempre lembrarei de vocês com muito carinho. Em especial às amigas que ganhei e tem lugar garantido no meu coração, Bruna, Lisara e Marília, vocês ajudaram a fazer tudo isso valer à pena. Obrigada de coração pelo apoio, pelos conselhos, pelas risadas e pelo ombro amigo em diversas situações. Obrigada Marília pelo pouso e por toda generosidade e amizade, vou sempre estar do teu lado para o que tu precisar. Obrigada Lis pela amizade sincera, pela disposição de sempre para ajudar e por todo carinho, tu tornou meus dias mais leves e felizes. Vou morrer de saudades, amo vocês! Às minhas queridas amigas de Santa Maria que me acolheram com carinho, Ana e Renata. Ana, obrigada pela ajuda e pelo apoio, és uma amiga muito querida, torço muito por ti. Rê amada, obrigada pela amizade, pela alegria e pelo carinho, tu é uma pessoa maravilhosa, sorte de quem te tem por perto. Obrigada queridas, amo vocês!.

(7) Ao meu querido amigo Rafa, que com humor e sinceridade alegra meus dias. Aos meus colegas de faculdade, em especial meus grandes amigos, Marina, Rafaela, Rafaelo e Renan, que torceram e comemoraram muito minha aprovação no mestrado, apesar de distantes vocês sempre vão morar no meu coração, amo vocês. Em especial à Marina (Zé) que a distância não prejudicou em nada a amizade e o carinho, obrigada pelo apoio quase diário, por me ouvir e por me entender tão bem, sempre daremos um jeito, te amo! À meus queridos amigos, Gabi Guido, Igor, Henrique e Carlos, obrigada por tornarem meus dias melhores, vocês fazem a diferença na minha vida, amo vocês. À minha querida amiga e colega de profissão Marília Fuller (Má), que mesmo muito longe se faz presente diariamente, dividindo momentos importantes da nossa vida. Obrigada por multiplicar meus momentos felizes e dividir minhas angústias, estaremos sempre juntas. Te amo! Às minhas amigas de infância, irmãs de coração, Duda, Kp e Mandy, nada disso seria possível sem vocês. Obrigada por me darem forças e motivos para sempre seguir em frente. Obrigada pela amizade sincera e pelos conselhos sempre tão pertinentes. Obrigada por serem meus anjos da guarda e estarem sempre comigo. Amo vocês! Aos meus familiares, em especial minha Tia Nica, Tia Osma e Tio Marcelo, que sempre acreditaram em mim e estiveram ao meu lado, obrigada por tudo, amo vocês!.

(8) RESUMO SOBREVIDA E FATORES DE RISCO À FALHAS DE RESTAURAÇÕES DE RESINA COMPOSTA EM CRIANÇAS COM CÁRIE DE ACOMETIMENTO PRECOCE. AUTORA: PÂMELA CAMPAGNA ORIENTADORA: PROFA. DRA. MARTA DUTRA MACHADO OLIVEIRA. No tratamento restaurador de cárie precoce da infância a resina composta tem sido amplamente utilizada, porém, ainda existe uma lacuna na literatura acerca do comportamento clínico deste material na dentição decídua, especialmente na primeira infância. O objetivo deste estudo clínico retrospectivo foi avaliar a sobrevida e fatores de risco associados à falhas de restaurações de resina composta realizadas em crianças com cárie de acometimento precoce atendidas na Clínica de Bebês da Universidade Federal de Santa Maria, RS. Um total de 78 restaurações em dentes decíduos de registros de 24 crianças com risco elevado de cárie (9 meninas e 15 meninos) foram incluídas no estudo. Dentes anteriores e posteriores foram aceitos, desde que a restauração tenha sido realizada à no mínimo um ano anteriormente as avaliações e tenha seguido os preceitos e técnicas preconizados na instituição (UFSM). Dois dentistas foram treinados para avaliar as restaurações sendo o índice de concordância intra examinador de 0,80 a 0,87 e o inter examinador 0,81. A longevidade das restaurações, até 30 meses de seguimento, foi avaliada utilizando o teste de sobrevivência de Kaplan-Meier. A análise de regressão Cox multivariada com fragilidade compartilhada foi utilizada para avaliar os fatores associados às falhas (p <0,05). O tempo médio de sobrevivência foi de 26 meses (IC 95%: 24,5-26,7). A sobrevida das restaurações atingiu 34,8% até 30 meses, com uma taxa de falha anual global de 20,0%. As restaurações que envolveram duas ou mais superfícies apresentaram 2,50 vezes mais risco de falha do que as restaurações de uma única superfície (p = 0,03). As restaurações realizadas em dentes vitais apresentaram menor risco de falha do que às realizadas em dentes submetidos à intervenção pulpar (FC: 0,25 IC 95%: 1,00-0,65; p = 0,00). Os pacientes com índice de placa maior que 20% tiveram mais risco de falha em suas restaurações (HR: 3,63; IC 95%: 1,29-10,2; p = 0,01). As restaurações de resina composta realizadas em pacientes com cáries da primeira infância representaram uma sobrevivência restrita após 30 meses de seguimento. As variáveis clínicas, como o número de superfícies restauradas, terapia pulpar e o controle do biofilme, podem desempenhar um papel importante na sobrevivência das restaurações de resina composta realizadas em crianças mais jovens com alto risco de cárie.. Palavras-chave: Análise de sobrevida. Dente decíduo. Falha de Restauração Dentária. Odontopediatria..

(9) ABSTRACT Survival and associated risk factors of composite restorations in children with earlychildhood caries. AUTHOR: PÂMELA CAMPAGNA SUPERVISIOR: PROFA. DRA. MARTA DUTRA MACHADO OLIVEIRA. In the restorative treatment of early childhood caries composite resin has been widely used, however, there is still a gap in the literature about the clinical behavior of this material in the deciduous dentition, especially in early childhood. The aim of this retrospective clinical study was to evaluate the survival and risk factors associated with failure of composite resin restorations performed in children with early-onset caries treated at the Baby Clinic of the Federal University of Santa Maria, RS. A total of 78 restorations in primary teeth from records of 24 high caries risk children (9 girls and 15 boys) were included in the study. Previous and subsequent teeth have been accepted, provided that the restoration has been performed at least a year before the evaluations and has followed the precepts and techniques recommended in the institution (UFSM). Two dentists were trained to evaluate the restorations with the intra-examiner concordance index of 0.80 to 0.87 and the inter-examiner 0.81. The restorations longevity up to 30 months of follow-up was assessed using the Kaplan-Meier survival test. Multivariate Cox regression analysis with shared frailty was used to evaluate the factors associated with failures (p<0.05).Mean survival time was 26 months (95%CI: 24.5-26.7). The survival of the restorations reached 34.8% up to 30 months, with an overall annual failure rate of the 20.0%. Restorations involving two or more surfaces had 2.50 times more risk of failure than restorations placed in cavities involving single surface (p=0.03).Restorations performed in vital teeth had a lower risk of failure than those performed in teeth underwent pulp intervention (HR: 0.25; 95%CI: 1.00-0.65; p = 0.00). Patients with plaque index more than 20% had more risk of failure in their restorations (HR: 3.63; 95% CI 1.29-10.2; p=0.01). Resin composite restorations placed in patients with early childhood caries presented restricted survival after 30 months of follow-up. Clinical variables such as number of restored surfaces, pulp therapy and poor biofilm control may play an important role in the survival of composite restorations performed in younger children with high caries risk. Keywords:Pediatric Dentistry. Restoration Failure. Survival Analysis. Tooth decay..

(10) SUMÁRIO. 1. INTRODUÇÃO GERAL.....................................................................14. 2. PROPOSIÇÃO..................................................................................17. 3 ARTIGO..................................................................................................18 3.1 Title Page – “Survival and associated risk factors of composite restorations in children with earlychildhood caries: a clinical retrospectivestudy ”……...……………………..……………………………..19 Abstract.............................................................................................20 Introduction.......................................................................................21 Material and methods.......................................................................22 Results..............................................................................................26 Discussion.........................................................................................28 References........................................................................................31 4. CONSIDERAÇÕES FINAIS..............................................................41. REFERÊNCIAS.........................................................................................42 ANEXO A – Carta de Aprovação do Comitê de Ética em Pesquisa da Universidade Federal de Santa Maria.......................................................46 ANEXO B – Normas para publicação da revista Pediatric Dentistry ...................................................................................................50 APÊNDICE A – Termo de Consentimento Livre e Esclarecido................56 APÊNDICE B -- Termo de Confidencialidade...........................................59 APÊNDICE C – Ficha Clínica utilizada na Clínica de Bebês da UFSM........................................................................................................60 APÊNDICE D –Ficha para transcrição dos dados dos prontuários clínicos.......................................................................................................64 APÊNDICE E – Ficha para avaliação das restaurações...........................65.

(11) 14. 1 INTRODUÇÃO. A dentição decídua contribui no desempenho. das funções. mastigatórias, de articulação, fonação e oclusão, sendo portanto, indispensável preservá-la em estado de saúde até seu período normal de esfoliação (ALENCAR;CAVALCANTI; BEZERRA, 2007). No entanto, a perda prematura destes dentes é um problema frequente, sendo a cárie a causa principal (PERES et al., 2013). Embora a prevalência da doença cárie tenha diminuído no Brasil, os índices encontrados para os primeiros anos de vida merecem uma atenção especial. O estudo de ROSENBLATT e ZARZAR, 2004, avaliou 468 crianças de 12 a 36 meses e através de exame clínico encontrou lesões de cárie precoce da infância em 133 crianças. Segundo a Academia Americana de Odontopediatria (AAPD), cárie precoce na infância é caracterizada como a presença de um ou mais dentes decíduos cariados (lesões cavitadas ou não), perdidos (devido à cárie) ou restaurados antes dos 71 meses de idade (BÜCHER et al., 2013). Outros profissionais denominam a cárie da primeira infância como uma epidemia silenciosa, já que dados nacionais sugerem que mais de 50% dos préescolares são acometidos pela doença (BRASIL, 2012). Além disso, as lesões cariosas são de natureza aguda e progressiva, sendo sua evolução capaz de causar grande destruição dentária, ou até mesmo sua perda. Tal condição pode causar complicações locais, sistêmicas, psicológicas e sociais, exigindo assim, tratamento imediato, restaurador e preventivo (LOSSO et al., 2009). A Organização Mundial da Saúde propõe metas para estimular países em desenvolvimento a adotarem medidas para melhorar seus indicadores em saúde bucal. A meta para 2010 era que 90% dos indivíduos de 05 anos de idade estivessem livres de cáries no Brasil. Todavia, dados de um levantamento epidemiológico realizado no Brasil em 2010 apontam que aos 05 anos de idade, somente 46,6 % das crianças estavam livres de cárie. Segundo este mesmo levantamento,.

(12) 15. uma criança brasileira de 05 anos possui, em média, 2,43 dentes com experiência de cárie, com predomínio do componente cariado, que é responsável por mais de 80% do índice (Brasil, 2012). Além disso, outros estudos realizados no Brasil indicam que a prevalência de cárie precoce na infância varia de 12 a 46%, sendo a faixa etária entre 01 e 03 anos, a mais acometida (BÖNECKER, 2002). O tratamento das lesões de cárie na infância envolve o controle da doença e a reversão dos sinais clínicos nos seus estágios iniciais. Já em casos que as lesões atingem dentina, apresentando ou não cavitação, há necessidade de tratamento operatório associada à medidas preventivas, a fim de modificar as condições que levaram ao desenvolvimento da doença cárie (LOSSO et al., 2009), principalmente nesta faixa etária, em que as crianças estão estabelecendo hábitos que perpetuarão pela vida inteira. A resina composta tem sido amplamente utilizada como material restaurador na clínica odontopediátrica, entre outras razões, por ser um material com propriedades adesivas, permitindo maior preservação da estrutura dentária, restringindo o preparo à remoção do tecido cariado. Também tem como vantagem a estética (KILPATRICK; NEUMANN 2007) e portanto, a maior aceitação pelos pacientes e responsáveis. Lesões de cárie precoce na infância possuem peculiaridades no tratamento no que diz respeito às questões comportamentais e de condicionamento. O atendimento nesta faixa etária exige uma maior habilidade do cirurgião dentista devido à reduzida capacidade de cooperação das crianças, o que pode influenciar negativamente na longevidade dos procedimentos restauradores (BÜCHER et al., 2013). Uma das dificuldades encontradas está na realização de alguns procedimentos obrigatórios no uso da resina composta, como por exemplo, o isolamento absoluto. Assim, o uso de intervenções anestesiológicas como sedação ou anestesia geral, tem sido recomendado para realização de tratamento restaurador em crianças com cárie de acometimento precoce (AAPD, 2016). A dificuldade de manejo comportamental nessa faixa etária também acaba inviabilizando a realização de ensaios clínicos controlados.

(13) 16. e randomizados que avaliem o comportamento clínico de restaurações realizadas em dentes decíduos durante a primeira infância (WAGGONER, 2014). Neste contexto, a realização de pesquisas baseadas na prática clínica parece ser uma boa estratégia para avaliar a longevidade das restaurações o mais próximo das situações reais (OPDAM et al., 2010). No entanto, poucos estudos retrospectivos investigaram a sobrevida. de. restaurações de resina composta realizadas em crianças com cárie de acometimento precoce (BUCHER et al., 2014; AMIN et al., 2016). A sobrevida de diferentes tratamentos restauradores realizados, sob anestesia geral, em crianças com cárie de acometimento precoce foi investigada considerando um total de 818 pacientes. Destas, 32,9% foram submetidos à reintervenção de algum tratamento restaurador durante os 03 anos de acompanhamento. Coroas de aço e restaurações de amálgama apresentam maior taxa de sobrevida em comparação com as restaurações de resina composta (AMIN et al., 2016). Por outro lado, alta taxa de sucesso clínico de restaurações de resina composta realizadas, sob anestesia geral, na primeira infância tem sido relatada na literatura. O estudo retrospectivo de BUCHER et al., 2014, avaliou 1.017 restaurações de resina composta realizadas em crianças com cárie precoce da infância em tratamentos sob anestesia geral. O tempo médio de acompanhamento foi de 30,9 meses com taxa de sucesso de 81,5%. Considerando que em muitos países, como o Brasil, os procedimentos restauradores em bebês geralmente são realizados sem emprego de abordagens farmacológicas para manejo comportamental, os resultados obtidos nos estudos supracitados não podem ser diretamente extrapolados. A despeito das evidências disponíveis, é incontestável que ainda existe uma lacuna na literatura acerca do comportamento clínico de restaurações de resina composta na dentição decídua, especialmente na primeira infância. Sendo assim, a realização de um estudo retrospectivo para avaliar o comportamento clínico de restaurações de resina composta em crianças com cárie de acometimento precoce se faz necessária..

(14) 17. 2 PROPOSIÇÃO. O objetivo desta dissertação é apresentar um artigo científico abordando a sobrevida e os fatores associados com as falhas de restaurações de resina composta em crianças com cárie de acometimento precoce..

(15) 18. 3 ARTIGO Esta dissertação está baseada nas normativas da Universidade Federal de Santa Maria. Por se tratar de pesquisa envolvendo seres humanos, o projeto de pesquisa deste trabalho foi submetido à apreciação do Comitê de Ética em Pesquisa da Universidade Federal de Santa Maria, tendo sido aprovado (ANEXO A). Sendo assim, esta dissertação é composta por um artigo que foi enviado para publicação na revista Pediatric Dentistry.. “ Survival and associated risk factors of composite restorations in children with earlychildhood caries: a clinical retrospective study ’’ Campagna P, Pinto LT, Lenzi TL, Ardenghi TM, Rocha RO, Oliveira MDM..

(16) 19. 3.1 Title Page. Survival and associated risk factors of composite restorations in children with earlychildhood caries: a clinical retrospective study. Pâmela Campagna MSc Student. Graduate Program in Dental Science, Federal University of Santa Maria, Brazil Lisara Tosatto Pinto MSc Student. Graduate Program in Dental Science, Federal University of Santa Maria, Brazil Tathiane Larissa Lenzi Professor Graduate Program in Dental Science, Federal University of Santa Maria, Brazil Thiago Machado Ardenghi Associate Professor. Department of Stomatology, Federal University of Santa Maria, Brazil Rachel de Oliveira Rocha Associate Professor. Department of Stomatology, Federal University of Santa Maria, Brazil Marta Dutra Machado Oliveira Associate Professor. Department of Stomatology, Federal University of Santa Maria, Brazil. . Correspondingauthor:. Marta Dutra Machado Oliveira Department of Stomatology, Federal University of Santa Maria, BrazilRua Marechal Floriano Peixoto, 1184, 97015-270, Santa Maria, RS, Brazil Phone: +55 55 3220 9266 E-mail address:marta@ufsm.br.

(17) 20. Abstract. Purpose: This clinical retrospective cohort university-based study assessed the survival and risk factors associated with failures of resin composite restorations placed in patients with early childhood caries. Methods: A total of 78 restorations in primary teeth from records of 24 high caries risk children (9 girls and 15 boys) were included in the study. The restorations’ longevity up to 30 months of follow-up was assessed using the Kaplan-Meier survival test. Multivariate Cox regression analysis with shared frailty was used to evaluate the factors associated with failures (p<0.05). Results: Mean survival time was 26 months (95%CI: 24.5-26.7). The survival of the restorations reached 34.8% up to 30 months, with an overall annual failure rate of the 20.0%. Restorations involving two or more surfaces had 2.50 times more risk of failure than restorations placed in cavities involving single surface (p=0.03). Restorations performed in vital teeth had a lower risk of failure than those performed in teeth underwent pulp intervention (HR: 0.25; 95%CI: 1.00-0.65; p = 0.00). Patients with plaque index more than 20% had more risk of failure in their restorations (HR: 3.63; 95% CI 1.29-10.2; p=0.01). Conclusion: Resin composite restorations placed in patients with early childhood caries presented restricted survival after 30 months of follow-up. Clinical variables such as number of restored surfaces, pulp therapy and poor biofilm control may play an important role in the survival of composite restorations performed in younger children with high caries risk.. Keywords: baby bottle-fed tooth decay; deciduous tooth; dental restoration; failure; survival analysis.

(18) 21. Introduction Early childhood caries (ECC)is defined as the presence of one or more decayed (non cavitated or cavitated lesions), missing (due to caries), or filled tooth surfaces in any primary tooth in a child under the age of six. 1 ECC remains a significant public health problem, since it results in higher risk of new caries lesions in both primary and permanent dentitions2 besides negatively impacts on oral health-related quality of life. 3,4 Restorative therapy is routinely performed in daily Pediatric clinic for treating rapid and extensive destruction of primary teeth promoted by ECC.5 However, restorative treatment may be a great challenge for the practioners due difficulties with behavior management of infants or toddlers. Moreover, anterior teeth are frequently affected by ECC. In this sense, small teeth dimensions, large carious lesions and, consequently, reduced are for bonding6 may jeopardize the longevity of the restorations. Resin-based composites have been generally used for restoring primary teeth, providing good handling and functional performance besides meeting patients’ demands regarding esthetics.7 There is a lack of supporting clinical data regarding the restoration of primary teeth of very young children. Child’s level of cooperation during treatment, parental consent, variability in the amount of remaining tooth structure, and differences in caries risk are barriers to obtaining good clinical data on restorative options.6 Thus, retrospective studies may provide relevant data about the longevity of resin-based composite restorations placed in primary dentition. A previous retrospective study8 found an overall success rate of.

(19) 22. 81.5% after a mean time of 30.7 months for composite restorations placed under general anesthesia in children with early childhood caries. However, anesthesiologic interventions, such as sedation or general anesthesia, are not a common approach in many countries for treatment of infants or toddlers. In this sense, dental treatment supported bynon-pharmacological behavior guidance techniques may reflect conditions closer to the clinical daily life. Therefore, the aim of this clinical retrospective cohort universitybased study was to evaluate the survival and factors associated with failures of resin composite restorations in patients with ECC.. Methods Ethical aspects and study design A retrospective longitudinal study was conducted. The research protocol was approved by the Local Research Board and the parents or guardians signed a written informed consent. The personal information of the children was kept confidential. Sample collection The convenience sample comprised children (0-3 years old) who underwent restorative treatment in Pediatric Dentistry Clinic at the Federal University of Santa Maria during the period between April 2013 and December 2015. Graduate students, supervised by specialists in Pediatric Dentistry, attended the children. Most patients have high risk of caries. To be included in the study, children should have received at least one resinbased composite restoration in primary teeth. The restorations should have been clinically and/or radiographically followed up for at least 1 year,.

(20) 23. and patients should have at least one visit at the clinic after the restoration placement. Children with compromised systemic health were excluded from the study. In total, 34 patients were selected through the inspection of clinical and radiographic records and invited to visit the dental office. The recruitment was performed by phone calls, and 24 (70.6%) patients agreed to participate in the clinical evaluations. Three teeth were lost to exfoliation four were extracted, leaving 78 restorations available for examination. Restorative procedures All procedures were performed under rubber dam isolation. Cavities were prepared with low-speed handpieces and dentin excavators were used for carious tissue removal; high-speed carbide burs were used for removing enamel and unsatisfactory restorations when necessary. Preparation was restricted to carious tissue removal. In deep and moderate cavities, a thin layer of calcium hydroxide cement (Dycal; Dentsply, Petrópolis, RJ, Brazil) was used. The cavity was conditioned by 37 % phosphoric acid gel for 15 s. The acid was removed by rinsing with water for 30 s, and the cavity was gently dried with air and cotton pellets. The two-step etch-and-rinse adhesive system (Adper Single Bond, 3M ESPE, St. Paul, MN, USA) was used prior to the incremental insertion of resin composite (Filtek Z250 or Z350, 3M ESPE, St. Paul. MN, USA). For the anterior and posterior proximal cavities, a matrix was adapted to the cervical margin. The rubber dam was then removed and the occlusion was checked. For all restorations, finishing and polishing were performed using fine-grained diamond burs, sandpaper strips and siliconized tips..

(21) 24. Data collection The history of the restorations was collected from the patient records. Factors potentially associated with treatment failure were investigated, including individual and clinical characteristics: gender (boys or girls), mother’s school level (up to eight years of formal education or more than eight years), household income (up to one Brazilian minimum wage (BMW) – nearly corresponded to 273 US dollars during the period of data gatheringor more than one BMW), type of arch (upper or lower),type of tooth (anterior or posterior), number of restored surfaces (one or two or more), pulp intervention (yes or no) and pulp capping material (yes or no). Training and calibration of evaluators Two dentists (P.C. and M.D.M.O) underwent a total of 8 h of specific training session involving theoretical explanations, discussion and assessment of 20 photographs on World Dental Federation (FDI) criteria. 9 FDI criteria include several items on aesthetic, functional and biological properties. Each criterion of FDI can be expressed with five scores, three for acceptable (1. clinically very good; 2. clinically good; 3. clinically sufficient/satisfactory). and. two. for. non-acceptable. (4.. clinically. unsatisfactory – repairable restoration; 5. clinically poor – restoration replacement).The responsible for training session was a benchmark examiner (T.L.L.) who has been trained and calibrated for using the criteria.. The. examiners’. calibration. procedures. considered. two. examinations of 10 restorations, randomly distributed in both periods to avoid memory bias, for Cohen’s Kappa calculation (Kappa = 0.81). Evaluation of restorations.

(22) 25. The children’s restorations were clinically evaluated between December 2016 and March 2017 independently by two trained and calibrated examiners using a dental probe and plane buccal mirror, in accordance with FDI criteria. In case of disagreement, the examiners evaluated the restorations jointly, until a consensus was reached. For the statistical analysis, the worst grading among all parameters of both criteria was considered. The restorations were considered as failed in case of replacement (score 5 by FDI) or repair (score 4), and the reason for failure was registered (as judged by clinician). The visible plaque index (Ainamo and Bay) was used to evaluate the routine of plaque control by children.10 For the calculation of these indexes, the number of dental surfaces was divided by the surfaces with visible plaque or gingival bleeding. For the analysis, the values of these two indexes were dichotomized. A satisfactory biofilm control was considered when the visible plaque index was less than 20 %. 11Those patients who presented treatment need during clinical evaluation were referred for treatment. Statistical analysis Data analyses were performed with STATA software 12.0 (Stata Corp., College Station, TX, USA). The descriptive analysis provides the distribution summary according to the independent variables. The annual failure rate (AFR) of the restorations was calculated according to the formula: (1− y)z =(1− x), in which “y” expresses the mean AFR and “x” the total failure rate at “z” years. Survival analysis was performed to assess factors associated with the longevity of the restorations, and data was.

(23) 26. censored at 30 months of follow-up. Survival curves of the restorations were assessed through the Kaplan-Meier method. Multivariate Cox regression models with shared frailty were performed to identify factors associated with failure of the restorations. These models consider that observations within the same group (the patient) are correlated, sharing the same frailty, being analogous to multilevel regression models with random effects. Hazard ratios (HR) and their respective 95% confidence intervals (CI) were obtained. A backward stepwise procedure was used to select covariates in the fitting of the model. Only those variables presenting P-values less than 0.2 in the unadjusted assessment were selected for the multivariate analysis. A significant level of 5% was considered for the final model.. Results Seventy and eight restorations placed in 24 patients (9 girls and 15 boys) were included in the analysis. The mean age of the children after follow-up was 5.4 years (±0.8), presenting a decayed, missing and filled teeth (dmf-t)mean of 7.8 (± 4.0).The follow-up period ranged from 15 to 30 months with a mean of 24 months(±5.1). Table 1 shows the distribution of restorations and their rates of “success” according to individual and clinical-level variables. Among all restorations considered in the analysis, 56 (71.8%) were placed in boys. Most restorations (67.9%) were performed in children with visible plaque index more than 20% in the follow-up. Posterior restorations were more frequent (51.3%) than anterior ones (48.7%) as well as those performed in.

(24) 27. upper arch (73.1%) when compared with lower arch (26.9%). Resin-based composite restorations placed on vital teeth were more common (80.8%) than those teeth with pulp treatment (19.2%) as well as those involving two or more surfaces (64.1%) in comparison with single surface (35.9%).In the majority of the restorations (93.6%) no pulp capping material was used. The overall success rate was 47.4%(37/78). Table. 2. shows. the. unadjusted and adjusted HR for failures according to independent variables. The adjusted model showed that restorations involving two or more surfaces had 2.50 times more risk of failure than restorations placed in cavities involving only one surface (p=0.03). Restorations performed in children with visible plaque index more than 20% had 3.63 times more risk of failure compared to patients with good biofilm control (p=0.01). The results also demonstrated that restorations placed in vital teeth had a lower risk of failure than those performed in teeth underwent pulp treatment (HR: 0.25;95%CI: 1.00-0.65; p = 0.00). The cumulative restoration survival estimate is shown in Figure 1. Mean survival time was 26 months (95%CI: 24.5-26.7), with 34.8% of the restorations surviving after 30 months of evaluation. The overall AFR after 24 months follow-up was 20.0%. The distribution of the restorations according to the FDI criteria is summarized in Table 3. Marginal adaptation, fracture and caries recurrence were the main reasons for need of intervention (repair or replacement) in the resin-based composite restorations. Discussion.

(25) 28. This cohort study involved the clinical evaluation of resin-based composite restorations performed in patients with ECC by undergraduate students and the factors associated with restoration failures. The overall survival rate of the restorations was 34.8% after 30 months of follow-up. Although the survival rate was low, it is important to note that the Kaplan Meier estimator takes into account the censored data, i.e., those restorations that have not yet reached the 30-month evaluation in this retrospective analysis. In addition, the reduced ability to manage a child’s behavior in association with lack of technical experience of the students could contribute to the restricted survival of restorative treatment. The overall AFR was 20.0%. A previous investigation8 found an ARF of 4.2% for composite restorations performed in children with ECC under general anesthesia. In our study, all procedures were made in association with non-pharmcological behavior guidance techniques, which could explain the higher AFR. Moreover, only individuals with high caries risk were included in the sample. It has been evidenced that these patients are more likely to present resin composite restorationfailure.12 In this sense, it would be interesting to consider other restorative treatment options such as fillings with materials less technically sensitive and zirconia or stainlees steel crowns.13,14 A retrospective study13 showed that stainlees steel crowns and amalgam restorations placed under general anesthesia for ECC had better survival than resin composite restorations over three-year follow-up. Furthermore, zirconia crowns have been shown clinically satisfactory yand very acceptable by parents. 14 Glass ionomer cements are widely used in Brazil to restore primary teeth.

(26) 29. due several advantages such as ease of the technique, which reduces chair time, being mainly important for treatment of uncooperative and very young children.15 Further studies evaluating the survival of resin-modified glass ionomer cement restorations in infants are required. In our study, the number of restored surfaces also had a detrimental effect over the longevity of the restorations. Teeth presenting two or more restored surfaces presented more failures when compared to one restored surface (HR 2.50; 95%CI: 1.08-5.78). It has been reported that a higher number of surfaces enrolled in cavity preparations can decrease the tooth resistance to fracture,16-18 even in primary teeth that had lower occlusion loading compared than permanent ones.19 It is well established in the scientific literature that dental biofilm is a marker for oral health patterns. A birth cohort study demonstrated that the lifetime exposure to dental biofilm might be a risk factor in cumulative dental diseases, such as caries, failure of restorative treatments, and tooth loss.20 Our results showed that patients presenting more sites with visible plaque (IPV >20 %) had 3.63 times more risk of failure in their restorations. Although gingival bleeding index is the clinical parameter more faithful reference from oral hygiene routine, this evaluation was not made because difficulties when applied in infant patients.21 Children with a history of pulpal intervention also presented higher risk of failure. Few studies have assessed the influence of endodontic treatment on restoration survival;22,23 however these reports also detected increased risk for failure in teeth with pulp intervention. This is probably due to reduction. in. tooth. structure. affecting. fracture. resistance24. and.

(27) 30. consequently, decreasing the restoration survival.25 Fracture, marginal adaptation, anatomic form and caries were the main reasons for failure of the restorations. However, most restorations could be repaired due fracture and marginal adaptation. This is friendlypatient approach for treating defective restorations in order to improve the restoration survival and diminish chair time.26 With regard to the limitations of this study, it must be considered in practice-based retrospective studies, patients are not specifically selected. A convenience sample of children attending a dental clinic was followed by a relatively short-term clinical and the sample size was small; so the findings presented here should be considered with caution. On the other hand, this study provides valuable information for clinicians and researches about clinical factors associated with failures of composite restorations performed in children with ECC.. Conclusion Resin composite restorations placed in patients with ECC presented restricted survival after 30 months of follow-up. Clinical variables such as number of restored surfaces, pulp therapy and poor biofilm control may play an important role in the survival of composite restorations performed in younger children with high caries risk.. References 1.. American Academy of Pediatria Dentistry (AAPD). Policy on early.

(28) 31. childhood caries (ECC): Classifications, consequences and preventive strategies. Ped Dent 2016;38:26–17. 2.. al-Shalan TA, Erickson PR, Hardie NA. Primary incisor decay before. age 4 as a risk factor for future dental caries. Pediatr Dent 1997;19:37–41. 3.. Martins-Júnior PA, Vieira-Andrade RG, Corrêa-Faria P, Oliveira-. Ferreira F, Marques LS, Ramos-Jorge ML. Impact of Early Childhood Caries on the Oral Health-Related Quality of Life of Preschool Children and Their Parents. Caries Res 2013;47:211–8. 4.. Filstrup SL, Briskie D, da Fonseca M, Lawrence L, Wandera A,. Inglehart MR. Early childhood caries and quality of life: child and parent perspectives. Pediatr Dent 2003;25:431–40. 5.. Finucane D. Rationale for restoration of carious primary teeth: a. review. Eur Arch Paediatr Dent 2012;13:281–92. 6.. Waggoner WF. Restoring Primary Anterior Teeth: Updated for 2014.. Pediatr 7.. Dent 2015; 37:163-70.. Dhar V, Hsu KL, Coll JA, et al. Evidence-based Update of Pediatric. Dental Restorative Procedures: Dental Materials. J Clin Pediatr Dent 2015;39:303–10. 8.. Bücher K, Tautz A, Hickel R, Kühnisch J. Longevity of composite. restorations in patients with early childhood caries (ECC). Clin Oral Investig 2014;18:775–82. 9.. Hickel R, Peschke A, Tyas M, et al. FDI World Dental Federation -. clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent 2010;12:259–72..

(29) 32. 10. Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J 1975;25:229–35. 11. Casagrande L, Seminario AT, Correa MB, et al. Longevity and associated risk. factors in adhesive restorations of young permanent. teeth after complete and selective caries removal: a retrospective study. Clin Oral Investig 2017;21:847- 55. 12. Correa MB, Peres MA, Peres KG, Horta BL, Barros AJ, Demarco FF. Do socioeconomic determinants affect the quality of posterior dental restorations? A multilevel approach. J Dent 2013;41:960–7. 13. Amin M, Nouri M-R, Hulland S, ElSalhy M, Azarpazhooh A. Success Rate of Treatments Provided for Early Childhood Caries under General Anesthesia: A Retrospective Cohort Study. Pediatr Dent 2016;38:317–24. 14. Holsinger DM, Wells MH, Scarbecz M, Donaldson M. Clinical Evaluation and Parental Satisfaction with Pediatric Zirconia Anterior Crowns. Pediatr Dent 2016;38:192–7. 15. Azevedo MS, Vilas Boas D, Demarco FF, Romano AR. Where and how are Brazilian dental students using Glass lonomer Cement? Braz Oral Res 2010;24:482–7. 16. Demarco FF, Corrêa MB, Cenci MS, Moraes RR ON. Longevity of posterior composite restorations: not only a matter of materials. Dent Mater. 2012;28:87–101. 17. Correa MB, Peres MA, Peres KG, Horta BL, Barros AJ DF. Do socioeconomic determinants affect the quality of posterior dental restorations? A multilevel approach. J Dent 2013;41:960–7. 18. Da RosaRodolpho PA, Donassollo TA, Cenci MS, et al. 22-Year.

(30) 33. clinical evaluation of the performance of two posterior composites with different filler characteristics. Dent Mater 2011;27:955–63. 19. Hickel R, Kaaden C, Paschos E, Buerkle V, García-Godoy F, Manhart J. Longevity of occlusally-stressed restorations in posterior primary teeth. Am J Dent 2005;18:198–211. 20. Broadbent JM, Thomson WM, Boyens J V, Poulton R. Dental plaque and oral health during the first 32 years of life. J Am Dent Assoc 2011;142:415–26. 21. Mariath AAS, Bressani AEL, Haas AN, Araujo FB de, Rösing CK. Professional flossing as a diagnostic method for gingivitis in the primary dentition. Braz Oral Res 2008;22:316–21. 22. Sande FH Van De, Opdam NJ, Rodolpho PADR, Correa MB, Demarco FF,. Cenci MS. Patient Risk Factors ’ Influence on Survival. of Posterior Composites.. J Dent Res 2013; 92:78S-83S.. 23. Pinto GDS, Oliveira LJC, Romano AR, et al. Longevity of posterior restorations in primary teeth: Results from a paediatric dental clinic. J Dent 2014;42:1248–54. 24. de V Habekost L, Camacho GB, Azevedo EC DF. Fracture resistance of thermal cycled and endodontically treated premolars with adhesive restorations. J Prosthet Dent 2007;98:186–92. 25. Ferrari M, Vichi A, Fadda GM, et al. A randomized controlled trial of endodontically treated and restored premolars. J Dent Res 2012;91:72S – 78S. 26. Gordan V V, Riley JL, Blaser PK, Mondragon E, Garvan CW, Mjör IA. Alternative treatments to replacement of defective amalgam restorations:.

(31) 34. results of a seven-year clinical study. J Am Dent Assoc 2011: 142: 842– 849..

(32) 35. Figure 1.Kaplan-Meier survival curve of restorations over 30 months..

(33) 36. Table 1. Status of the restorations according to clinical and demographic characteristics (n=78 restorations) n (%) of restorations. Success (%). Failure (%). 56 (71.8) 22 (28.2). 26 (46.4) 11 (50.0). 30 (53.6) 11 (50.0). 36 (46.2). 17 (47.2). 19 (52.8). 42 (53.8). 20 (47.6). 22 (52.4). 40 (51.3). 22 (55.0). 18 (45.0). 38 (48.7). 15 (39.5). 23 (60.5). 25 (32.1) 53 (67.9). 12 (48.0) 23 (43.4). 13 (52.0) 30 (56.6). Type of arch Upper Lower. 57 (73.1) 21 (26.9). 27 (47.4) 10(47.6). 30 (52.6) 11 (52.4). Type of tooth Anterior Posterior. 38 (48.7) 40 (51.3). 17 (44.7) 20 (50.0). 21 (55.3) 20 (50.0). Number of restored surfaces One Two or more. 28 (35.9) 50 (64.1). 17 (60.7) 20 (40.0). 11 (39.3) 30 (60.0). Pulp intervention Yes No. 15 (19.2) 63 (80.8). 5 (33.3) 32 (50.8). 10 (66.7) 31 (49.2). Pulp capping material Yes No. 5 (6.4) 73 (93.6). 2 (37.5) 35 (48.0). 3 (62.5) 38 (52.0). Variables Gender Boys Girls Mother's education Up to eight years More than eight years Income Up to one minimum wage More than one minimum wage Visible plaque index (follow-up) Up to 20% More than 20%.

(34) 37. Table 2. Unadjusted and adjusted Hazard Ratios (HR;95%CI) for failure of the restorations. according to clinical and demographic characteristics. Cox regression model. Variables. HRcrude (95%CI). Gender Boys Girls. More than eight years. 1.08 (0.472.55) 0.43 1 1.50 (0.723.12) 0.28. Up to one minimum wage. 1. More than one minimum wage. 1.08 (0.681.74). Visible plaque index (follow-up). More than 20%. pvalue. 1. Income. Up to 20%. HRadjusted (95%CI). 0.84. Mother's education Up to eight years. pvalue. 0.01. 0.05 1. 1. 2.57 (1.026.47). 3.63 (1.2910.2). Type of arch Superior. 1. Inferior. 0.79 (0.381.65). Type of tooth. 0.78. Anterior. 1. Posterior. 0.86 (0.451.67). Number of restored surfaces One. Two or more. 0.53. 0.03. 0.04 1. 1. 2.17 (1.034.54). 2.50 (1.085.78).

(35) 38. Pulp intervention. 0.00. 0.00. Yes. 1. 1. No. 0.22 (0.090.53). 0.25 (0.100.65). Pulp capping material. 0.28. Yes. 1. No. 0.51 (0.151.73) * P-values > 0.05 in the adjusted model..

(36) 39. Table 3. Clinical evaluation of the restorations according to the World Dental Federation (FDI) criteria.. General evaluated criteria. Specific evaluated criteria. Esthetics properties. Functional properties. 1. 2. 3. 4. 5. Surfaceluster. 51 (65.4). 9 (11.5). 2 (2.6). -. 16 (20.5). Surface staining. 38 (48.7). 24 (30.8). -. -. 16 (20.5). Marginal staining. 18 (23.1). 42 (53.8). 2 (2.6). -. 16 (20.5). Translucency and color stability. 17 (21.8). 26 (33.3). 17 (21.8). 1 (1.3). 17 (21.8). Anatomic form. 12 (15.4). 20 (25.6). 22 (28.2). 5 (6.4). 19 (24.4). Fracture. 36 (46.1). 7 (9.0). 6 (7.7). 10 (12.8). 19 (24.4).

(37) 40. Biological properties. Marginal Adaptation. 5 (6.4). 28 (35.9). 11 (14.1). 15 (19.2). 19 (24.4). Caries recurrence. 45 (57.7). 5 (6.4). 2 (2.6). 4 (5.1). 22 (28.2).

(38) 41. 4 CONSIDERAÇÕES FINAIS Com base neste estudo retrospectivo clínico, observou-se uma limitada sobrevida de restaurações de resina composta em pacientes acometidos por cárie precoce de infância. Tais resultados são decorrentes das dificuldades no manejo comportamental desses pacientes, associado ao padrão de destruição da estrutura dentária acometida pela doença cárie nesta faixa etária. Variáveis clínicas relacionadas ao número de superfícies restauradas, presença de intervenção pulpar e deficiente controle de biofilme foram associadas às falhas restauradoras. Ademais, a maioria das crianças apresentaram baixo nível socioeconômico e alto risco de cárie, fatores sociais determinantes e individuais que afetam diretamente a qualidade das restaurações adesivas (Demarco et al., 2013; Correa et al., 2012). Sendo assim, fica evidente que o principal desafio do Odontopediatra é o sucesso na implementação de medidas preventivas e de promoção de saúde a fim de postergar ou evitar a necessidade de intervenção invasiva..

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(43) 46. Anexo A –Aprovação do Comitê de Ética em Pesquisa da UFSM.

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(47) 50. ANEXO B - Normas do periódico Pediatric Dentistry.

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(53) 56. Apêndice A - Termo de Consentimento Livre e Esclarecido.

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(56) 59. Apêndice B – Termo de confidencialidade.

(57) 60. Apêndice C – Ficha Clínica utilizada na Clínica de Bebês da UFSM.

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(61) 64. Apêndice D – Ficha para transcrição dos dados dos prontuários.

(62) DENTE 10. Sensibilidade pós-operatória. 9. Integridade dental. 8. Recorrência da patologia. 7. Percepção do paciente. 6. Adaptação marginal. 5. Fratura. 4. Forma anatômica. 3. Estabilidade de cor e translucidez. 2.b. Manchamento marginal. 2.a. Manchamento superficial. PACIENTE:. 1. Brilho superficial. 65. Apêndice E - Ficha para avaliação das restaurações Examinador 1. DATA DO EXAME Examinador 2. Propriedades Propriedades Propriedades. Estéticas Funcionais Biológicas.

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